Platform Acetabular Cup with Ti-Coat

GUDID 00814703017377

Acetabular Cup with Ti-Coat, size 44mm

TOTAL JOINT ORTHOPEDICS, INC.

Metallic acetabulum prosthesis
Primary Device ID00814703017377
NIH Device Record Keyfcd0d3a3-d741-48ab-a1de-af458cbb5fe2
Commercial Distribution StatusIn Commercial Distribution
Brand NamePlatform Acetabular Cup with Ti-Coat
Version Model Number3401.44.000
Company DUNS078416717
Company NameTOTAL JOINT ORTHOPEDICS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(801)486-6070
Emailudi@tjoinc.com
Phone+1(801)486-6070
Emailudi@tjoinc.com
Phone+1(801)486-6070
Emailudi@tjoinc.com
Phone+1(801)486-6070
Emailudi@tjoinc.com
Phone+1(801)486-6070
Emailudi@tjoinc.com
Phone+1(801)486-6070
Emailudi@tjoinc.com
Phone+1(801)486-6070
Emailudi@tjoinc.com
Phone+1(801)486-6070
Emailudi@tjoinc.com
Phone+1(801)486-6070
Emailudi@tjoinc.com
Phone+1(801)486-6070
Emailudi@tjoinc.com
Phone+1(801)486-6070
Emailudi@tjoinc.com
Phone+1(801)486-6070
Emailudi@tjoinc.com
Phone+1(801)486-6070
Emailudi@tjoinc.com
Phone+1(801)486-6070
Emailudi@tjoinc.com
Phone+1(801)486-6070
Emailudi@tjoinc.com

Device Dimensions

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Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
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Device Size Text, specify0

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic HD Hip System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic HD Hip System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic HD Hip System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic HD Hip System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic HD Hip System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic HD Hip System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic HD Hip System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic HD Hip System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic HD Hip System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic HD Hip System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic HD Hip System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic HD Hip System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic HD Hip System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic HD Hip System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic HD Hip System should be stored in a clean, dry location at room temperature

Device Identifiers

Device Issuing AgencyDevice ID
GS100814703017377 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MBLProsthesis, hip, semi-constrained, uncemented, metal/polymer, porous

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00814703017377]

Radiation Sterilization


[00814703017377]

Radiation Sterilization


[00814703017377]

Radiation Sterilization


[00814703017377]

Radiation Sterilization


[00814703017377]

Radiation Sterilization


[00814703017377]

Radiation Sterilization


[00814703017377]

Radiation Sterilization


[00814703017377]

Radiation Sterilization


[00814703017377]

Radiation Sterilization


[00814703017377]

Radiation Sterilization


[00814703017377]

Radiation Sterilization


[00814703017377]

Radiation Sterilization


[00814703017377]

Radiation Sterilization


[00814703017377]

Radiation Sterilization


[00814703017377]

Radiation Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-10-06
Device Publish Date2022-09-28

On-Brand Devices [Platform Acetabular Cup with Ti-Coat ]

00814703017476Acetabular Cup with Ti-Coat, size 64mm
00814703017469Acetabular Cup with Ti-Coat, size 62mm
00814703017452Acetabular Cup with Ti-Coat, size 60mm
00814703017445Acetabular Cup with Ti-Coat, size 58mm
00814703017438Acetabular Cup with Ti-Coat, size 56mm
00814703017421Acetabular Cup with Ti-Coat, size 54mm
00814703017414Acetabular Cup with Ti-Coat, size 52mm
00814703017407Acetabular Cup with Ti-Coat, size 50mm
00814703017391Acetabular Cup with Ti-Coat, size 48mm
00814703017384Acetabular Cup with Ti-Coat, size 46mm
00814703017377Acetabular Cup with Ti-Coat, size 44mm

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